Under FDA’s priority process, Gardasil (the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18) has been approved recently by the USFDA.
Gardasil, manufactured by Merck & Co., Inc., is a recombinant vaccine (contains no live virus) that is given as three injections over a six-month period, approved in females 9-26 years of age.
"This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA's commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults," said Jesse Goodman, MD, MPH, Director of FDA's Center for Biologics Evaluation and Research.Read the full FDA press release.
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» Merck's Gardasil for HPV Protects Older Women Also from PharmaGazette
Merck & Co. (NYSE:MRK) released a study that its Gardasil HPV (human papillomavirus) vaccine may offer protection to women over the current FDA approved age range of 9 to 26.The study, which consisted of 3,800 women between the ages of... [Read More]
Tracked on: November 5, 2007 10:16 AM | Permalink to Trackback